Patritumab deruxtecan BLA submission receives complete response letter from FDA due to inspection findings at third-party manufacturer
- The FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of patritumab deruxtecan for EGFR-mutated NSCLC.
- The CRL was due to inspection findings at a third-party manufacturing facility, not related to the drug's efficacy or safety.
- Patritumab deruxtecan is a HER3 directed DXd antibody drug conjugate developed by Daiichi Sankyo and Merck.
- The BLA was based on results from the HERTHENA-Lung01 phase 2 trial, showing an objective response rate (ORR) of 29.8%.
- The trial included 225 patients with EGFR-mutated NSCLC, showing a median duration of response of 6.4 months.
- Next steps involve working closely with the FDA and the third-party manufacturer to address the feedback.
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EPKINLY (epcoritamab-bysp) approved by U.S. FDA for patients with relapsed or refractory follicular lymphoma
- The U.S. FDA has approved EPKINLY (epcoritamab-bysp) for adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
- Approval is based on results from the Phase 1/2 EPCORE NHL-1 study, which showed an overall response rate (ORR) of 82% and a complete response (CR) rate of 60%.
- EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in the U.S. for this patient population.
- Common treatment-emergent adverse events (TEAEs) included injection site reaction, cytokine release syndrome (CRS), COVID-19, fatigue, and upper respiratory tract infection.
- The National Comprehensive Cancer Network (NCCN) has updated its guidelines to include EPKINLY as a Category 2A, preferred recommendation for third-line and subsequent therapy for patients with FL.
- Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial(s).
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U.S. FDA grants second approval for epkinly to treat patients with relapsed or refractory follicular lymphoma
- EPKINLY is the first and only bispecific antibody approved in the U.S. for both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL).
- The approval is under the FDA's Accelerated Approval program based on overall response rate (ORR) and durability of response.
- The Phase 1/2 EPCORE NHL-1 clinical trial showed an ORR of 82%, with a complete response rate of 60% and a partial response rate of 22%.
- Safety was evaluated in 213 patients, with common adverse reactions including injection site reactions, cytokine release syndrome (CRS), and fatigue.
- EPKINLY is co-developed by AbbVie and Genmab, with shared commercial responsibilities in the U.S. and Japan.
- AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets.
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University of Nebraska Medical Center launches patient enrollment for RenovoRx’s pivotal phase III TIGeR-PaC clinical trial
- University of Nebraska Medical Center (UNMC) is enrolling patients with locally advanced pancreatic cancer (LAPC) in RenovoRx’s Phase III TIGeR-PaC clinical trial.
- The trial uses RenovoRx’s TAMP (Trans-Arterial Micro-Perfusion) therapy platform to evaluate the RenovoGem drug-device combination.
- RenovoGem delivers chemotherapy directly to tumor tissue, aiming to improve drug penetration and effectiveness.
- The study compares TAMP therapy to the current standard-of-care, systemic intravenous chemotherapy.
- The primary endpoint is a 6-month overall survival benefit, with secondary endpoints including reduced side effects.
- The second interim analysis will be triggered by the 52nd event, estimated to occur in late 2024.
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GenVivo announces initiation of patient dosing in a US Phase I/Ib clinical trial evaluating GEN2 in patients with advanced solid tumors
- GenVivo has started dosing the first US patient in a Phase I/Ib clinical trial for GEN2.
- The trial, GVO-1102, aims to establish the Recommended Phase 2 Dose (RP2D) and will expand into three solid tumor types.
- GEN2 is a non-replicating mRNA gene therapy vector designed to kill tumors and activate the patient's immune system.
- The trial will assess safety, tolerability, pharmacokinetics, and exploratory biomarkers.
- GEN2 offers the benefits of personalized therapy without the delays and costs of autologous products or tumor genome sequencing.
- The trial is currently enrolling US patients with advanced solid tumors who have not responded to prior therapies.
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X4 Pharmaceuticals announces positive interim clinical data from ongoing six-month phase 2 trial of mavorixafor in chronic neutropenia and initiation of pivotal phase 3 CN trial
- 100% of evaluable participants at Month 6 achieved target absolute neutrophil count (ANC) increase with once-daily, oral mavorixafor +/- stable-dose G-CSF.
- Durable mean ANC levels above the lower limit of normal for CN were achieved for participants on mavorixafor monotherapy at Months 3 and 6.
- The company is currently screening patients for enrollment into its global, pivotal Phase 3 clinical trial, the 4WARD study.
- The 52-week Phase 3 trial is a randomized, double-blind, placebo-controlled, multicenter study aiming to enroll 150 participants.
- Interim analysis showed mavorixafor was generally well tolerated and durably increased participants’ ANC both as a monotherapy and in combination with stable doses of G-CSF.
- No drug-related serious adverse events were reported, and the overall safety profile remains consistent with previous clinical studies.
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Resolution Therapeutics receives MHRA approval to commence Phase I/II EMERALD study for lead candidate RTX001
- Resolution Therapeutics has received approval from the U.K. MHRA to start the Phase I/II EMERALD study for RTX001.
- The EMERALD study will investigate the safety and efficacy of engineered macrophage cell therapy in patients with decompensated liver cirrhosis.
- Primary analysis will focus on safety and major clinical events, including death, and will evaluate biomarkers like the MELD score.
- The study is set to begin in Q3 2024.
- The approval follows key proof of concept data presented at the EASL Congress 2024, demonstrating the effectiveness of non-engineered macrophage cell therapy for advanced liver cirrhosis.
- Resolution Therapeutics will host an R&D Webinar on June 28, 2024, featuring hepatologist Arun Sanyal, M.D.
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Clinical study showing ClarityDX Prostate accurately predicts a patient's risk of having clinically significant prostate cancer published in Nature Digital Medicine
- Results of an international multi-center study evaluating ClarityDX Prostate's accuracy are now public.
- The study, published in npj Digital Medicine, highlights the test's use of machine learning and blood-based biomarkers.
- ClarityDX Prostate showed 95% sensitivity, 35% specificity, 54% positive predictive value, and 91% negative predictive value.
- The test could potentially avoid up to 35% of unnecessary prostate biopsies.
- ClarityDX Prostate was found to be three times more accurate than other risk calculators and PSA alone.
- The study supports using ClarityDX Prostate as an adjunctive test for men with elevated PSA levels.
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New survey from NCCN finds cancer drug shortage management remains a moving target, impacting clinical trials
- NCCN's latest survey reveals ongoing cancer drug shortages in the US, with 89% of centers reporting shortages of at least one type of systemic therapy.
- Specific shortages of carboplatin and cisplatin have decreased to 11% and 7% respectively, but new concerns have emerged.
- 57% of surveyed centers reported a shortage of vinblastine, 46% for etoposide, and 43% for topotecan.
- Drug shortages are affecting clinical trials at 43% of centers, impacting budgeting, enrollment, and increasing administrative burden.
- 27% of centers reported treatment delays due to shortage-related changes requiring additional prior authorization.
- NCCN advocates for sustainable, long-term solutions, including economic incentives for generic drugmakers to ensure a stable supply of high-quality cancer medications.
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Fostrox + Lenvima holds promise of greatly improved outcomes for advanced liver cancer patients, reveals new data from Medivir at ESMO GI
- Medivir presented new data from its Phase 1b/2a open-label trial of fostrox + Lenvima at the ESMO GI Congress.
- The combination achieved a 24% overall response rate (ORR) and a median time to progression (TTP) of 10.8 months.
- One patient remains on treatment after 22 months, showing a sustained partial response.
- Biopsies confirmed selective DNA damage to tumor cells with no impact on normal liver function.
- Only 5% of patients had to discontinue due to adverse events, indicating a favorable safety profile.
- Medivir is finalizing the study protocol to open an IND in the US, expected in H2 2024.
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